Regulators are tightening up on post-marketing monitoring of biological medicines to detect deficiencies caused by manufacturing problems,...
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Combination Products Challenge Regulators and Manufacturers
Combination drug products are high on everyone’s radar screen, as seen in continuing discussion about appropriate testing and regulation of self-injectors, such as EpiPen,...
Biosimilars Face Repercussions of Drug Pricing Debate
As more biosimilars gain FDA approval for marketing in the United States, and more manufacturers launch programs to develop additional competitive biotech therapies,...
5 Critical Areas of Combination Drug Compliance
Combination drug products are complex to both develop and to manage from a compliance perspective. This presentation discusses five critical areas of combination drug...
The Formation of the Combination Products Policy Council to Improve Regulatory Efficiency
Combination drug products (i.e., products that are a combination of a medical device and/or a drug and/or a biologic) are inherently complex to manage, particularly due to...
Bringing Legacy Combination Products into Compliance with 21 CFR Part 4
At the CASSS CMC Strategy Forum in July of this year, BioTechLogic’s Tracy TreDenick, Head of Regulatory and Quality and Senior Consultant, delivered a presentation...